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NCT Number: NCT06062953

Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia

The goal of this investigator-initiated, randomized, blinded, 3-armed placebo-controlled, pragmatic, clinical superiority trial is to examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia in patients with psychiatric disorders. The aims of the study are:

* To examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia * To examine how melatonin or low-dose quetiapine affects global symptom severity, sleep quality, psychosocial functioning and subjective well-being.

Participants will receive six weeks of treatment with either melatonin, quetiapine or placebo followed by a brief taper off.

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Key information

Conditions

Psychiatric Disorders Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

16 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mental Health Center Copenhagen

Copenhagen NV, 2400, Denmark

Location status: Recruiting

Location contact

Ursula Brinck-Claussen, MD

CONTACT

[email protected]

+4520483136

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 16 to 64 years of age
  • ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-95)
  • For the diagnoses F84 and F90 a previous period of treatment with melatonin is required
  • For the 16-17 years old: Non-pharmacological treatment options including sleep hygiene education, weighted blanket or other gravity products have been tested with insufficient effect
  • Self-reported sleep difficulties at least three times per week in the preceding 3 months
  • Insomnia Severity Index score ≥11
  • Women of childbearing potential: negative pregnancy test at baseline and use of highly effective contraception measures
  • Informed consent

Exclusion criteria

  • Current treatment with melatonin or quetiapine
  • Severe somatic comorbidity
  • BMI ≥ 35 kg/m2
  • Breastfeeding
  • Alcohol and/or substance dependency within the last 3 months
  • Inadequate Danish language skills
  • Not able to make an informed consent
  • Increased cardiac risk as assessed by presence of cardiac risk factors, cardiac symptoms, or prolonged QT-interval at baseline ECG

Treatment and study plan

Melatonin

Drug

3-9 mg flexible dosing before bed time

Quetiapine

Drug

50-150 mg flexible dosing before bed time

Placebo

Drug

1-3 capsules flexible dosing before bed time

Primary outcomes

  1. Insomnia severity

    Time frame: 6 weeks

    Insomnia Severity Index, range 0-28, higher is worse

Secondary outcomes

  1. Clinical global impression (CGI)

    Time frame: 6 weeks

    Clinical global impression: Severity, range 0-7, higher is worse

  2. Subjective sleep quality

    Time frame: 6 weeks

    Pittsburgh Sleep Quality Index, range 0-21, higher is worse

  3. Psychosocial functioning

    Time frame: 6 weeks

    Personal and Social Performance Scale, range 1-100, higher is better

  4. Patient-reported subjective well-being

    Time frame: 6 weeks

    WHO-5 well-being index, range 0-100, higher is better

Other outcomes

  1. Objective sleep quality (polysomnography)

    Time frame: 6 weeks

    Total sleep time in minutes, higher is better

  2. Circadian rhythmicity (actigraphy)

    Time frame: 6 weeks

    Interdaily stability which quantifies the invariability from day to day, i.e., the predictability of the 24 h rest-activity pattern. This index will be 1 for perfect interdaily stability and thus lower values reflect higher variability between the observed days

Study contacts

Contact information is provided by the study sponsor or research team.

Lone Baandrup, MD

CONTACT

[email protected]

+4591165903

Sponsors and collaborators

Lead sponsor

Lone Baandrup

Other

Collaborators

  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • Danish Center for Sleep Medicine
  • Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
  • Region Capital Denmark

Registry information

Official study title

Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia: a Randomized Clinical Trial

Acronym: MEL-QUE

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Oct 2, 2023
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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